Device product
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Z-2205-2026
Product summary
- Event
- Event 98992
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-2205-2026
Official wording
Reason: During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
Code information: UDI: 4056869046877
Distribution pattern: US and Worldwide
Derived failure modes
-
Unknown
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.